| Primary Device ID | 00850005780168 | 
| NIH Device Record Key | 4d33c617-ca4b-4ff7-9d7a-2267895d3291 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | GU Tek | 
| Version Model Number | UCA5-95 | 
| Catalog Number | UCA5-95 | 
| Company DUNS | 118877356 | 
| Company Name | V L V ASSOCIATES (INC) | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | true | 
| MRI Safety Status | Labeling does not contain MRI Safety Information | 
| Human Cell/Tissue Product | false | 
| Device Kit | false | 
| Device Combination Product | false | 
| Single Use | true | 
| Lot Batch | true | 
| Serial Number | false | 
| Manufacturing Date | false | 
| Expiration Date | true | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | true | 
| RX Perscription | true | 
| OTC Over-The-Counter | false | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00850005780168 [Primary] | 
| EYK | Connector, Ureteral Catheter | 
| Steralize Prior To Use | false | 
| Device Is Sterile | true | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2020-07-23 | 
| Device Publish Date | 2020-07-15 | 
| 00850005780168 - GU Tek | 2020-07-23Ureteral Catheter Connecting Adapter | 
| 00850005780168 - GU Tek | 2020-07-23 Ureteral Catheter Connecting Adapter | 
| B5911425L3 - EZ Access™ | 2018-03-29 Wound Protector/ Retractor | 
| B5911425M3 - EZ Access™ | 2018-03-29 Wound Protector/ Retractor | 
| B5911425S3 - EZ Access™ | 2018-03-29 Wound Protector/ Retractor | 
| B5911425XL3 - EZ Access™ | 2018-03-29 Wound Protector/ Retractor | 
| B5911425XS3 - EZ Access™ | 2018-03-29 Wound Protector/ Retractor |